Table 4.
Serum tremelimumab and sasanlimab pharmacokinetics parameters
| Tremelimumab 80 mg SC (N=6) |
Sasanlimab 300 mg SC (N=14) |
Sasanlimab 130 mg SC (N=11) |
|
| AUC0-672h, ng×hour/mL | |||
| n | 6 | 13 | 11 |
| Geometric mean (geometric CV, %) | 2,389,000 (32) | 10,250,000 (44) | 4,289,000 (44) |
| Arithmetic mean (SD) | 2,480,000 (666,930) | 11,040,000 (4,117,100) | 4,621,000 (1,778,300) |
| Median (range) | 2,645,000 (1,330,000–3,270,000) |
9,810,000 (3,940,000–17,600,000) |
4,410,000 (1,820,000–8,010,000) |
| Cmax, ng/mL | |||
| n | 6 | 14 | 11 |
| Geometric mean (geometric CV, %) | 4360 (31) | 19,960 (40) | 8612 (44) |
| Arithmetic mean (SD) | 4520 (1246.8) | 21,250 (7241.6) | 9266 (3491.3) |
| Median (range) | 4635 (2600–6100) | 21,050 (8970–31,100) | 9710 (3540–16,300) |
| Tmax, hour | |||
| n | 6 | 14 | 11 |
| Median (range) | 307 (165–477) | 188 (67.3–378) | 165 (71.0–380) |
| Rac, Ctrough | N=35 | N=16 | N=8 |
| n | 33 | 15 | 8 |
| Geometric mean (geometric CV, %) | 1.454 (73) | 0.7794 (220) | 0.2734 (253) |
| Arithmetic mean (SD) | 1.671 (0.7129) | 1.269 (0.8723) | 0.7980 (1.3647) |
| Median (range) | 1.530 (0.101–3.10) | 1.210 (0.0507–2.85) | 0.1540 (0.0988–3.89) |
AUC0–672h, area under the serum concentration-time profile from time 0 to 672 hours; Cmax, maximum serum concentration; n, number of patients included in the summary statistics; N, total number of patients in the indicated population; Rac, Ctrough, observed accumulation ratio for Ctrough at Day 29 to Day 1; Tmax, time for Cmax.
AUC, area under the curve; CV, coefficient of variation; SC, subcutaneous.